Expert Insights | Medical Devices

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
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High-Risk IVDs Drive Immediate Transition to IVDR
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Regulations

High-Risk IVDs Drive Immediate Transition to IVDR

March 11, 2025 3 min read
Top 5 Upcoming FDA and EU Regulations – What to Know for 2025
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Regulations

Top 5 Upcoming FDA and EU Regulations – What to Know for 2025

January 13, 2025 4 min read
Breaking Sterilization Barriers – EPA’s Bold Move Towards Safer Medical Device Regulation
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Medical Devices

Breaking Sterilization Barriers – EPA’s Bold Move Towards Safer Medical Device Regulation

March 18, 2024 2 min read
European Commission Proposes to Extend IVDR Transition and Accelerate EUDAMED Adoption
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Medical Devices

European Commission Proposes to Extend IVDR Transition and Accelerate EUDAMED Adoption

January 25, 2024 2 min read
FDA and Clinical Trials Transformation Initiative (CTTI) Collaborate to Improve ClinicalTrials.gov
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Medical Devices

FDA and Clinical Trials Transformation Initiative (CTTI) Collaborate to Improve ClinicalTrials.gov

January 19, 2024 2 min read
MHRA Releases Roadmap of Future UK Medical Device Regulation
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Medical Devices

MHRA Releases Roadmap of Future UK Medical Device Regulation

January 16, 2024 2 min read
Understanding FDA’s Guidance on Medical Device Export Certificates
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Medical Devices

Understanding FDA’s Guidance on Medical Device Export Certificates

December 5, 2023 4 min read
Managing Legacy Medical Device Cybersecurity Risks- What You Need to Know!
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Medical Devices

Managing Legacy Medical Device Cybersecurity Risks- What You Need to Know!

November 30, 2023 6 min read
Five Major Principles for Predetermined Change Control Plans Regarding Machine Learning-Enabled Devices
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Medical Devices

Five Major Principles for Predetermined Change Control Plans Regarding Machine Learning-Enabled Devices

October 30, 2023 4 min read
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